MAUDE Adverse Event Report: COLTENE WHALEDENT INC. FIESTA; DENTAL CLAMP

Model Number H09964

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2018

Event Type  malfunction  

Event Description

The dental clamp broke during use while the dentist used the clamp in the mandibular lower jaw starting from number 6.

• Brand Name: FIESTA
• Type of Device: DENTAL CLAMP
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 7800595
• MDR Text Key: 118107219
• Report Number: 2416455-2018-00011
• Device Sequence Number: 1
• Product Code: EEF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H09964
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1